Generic Insulin?

I have heard rumors that there will be a generic form of certain
insulins available in the near future. I did some research. I did
some research and found the article below:,_humalog_and_novolog_generics_463683

The article refers to Lantus as a fast acting insulin. That is NOT true!
The article may not be credible! Maybe they meant Apidra, instead of
Lantus. Apidra is a fast acting insulin.

If generic insulins do eventually appear, what will it mean? Will our
insurance require that we use generic? If so, will generic insulin
work properly for everyone? I doubt it!

The only difference between generic and brand name drugs are the price and the marketing. I applaud them and hope the manage to bring their products to worldwide market as fast as possible. Yes Lantus is not a fast acting insulin, clearly whoever wrote this got that wrong... Presumably if your prescription coverage requires generic preference, then the same would apply to insulin. This is no loss at all. It probably also would drive the price of all insulin down to very reasonable levels... eg the $25 vials of generic R and NPH available at walmart

As far as I can judge, Sam is right: this is a good thing! I have always used generics when available for the same reason: It is the same medication although without the mark-up. I especially applaud this move for how it will affect diabetics in developing countries who are unable to afford the modern insulins you and I thrive on!

Both our basal and bolus insulins are biologics, i.e. are produced by biological processes, where things like e coli are genetically modified to produce insulin with desired properties. The challenges to producing generics of these incredibly complex protein molecules are not trivial. I don't think the generics would end up being exact copies, though they would need to be certified to be sufficiently similar (I suppose in theory they might even represent improvements). The testing involved means that at least in terms of development and time to market, they're probably better thought of as new drugs. Biologics represent such a big, and growing, slice of the pharma market these days that generics are inevitable, but I suspect it'll take some time before we see generic versions of current insulins, and by then the brand name manufacturers may well have moved on, there's significant room for improvement in matching insulin action to carb digestion, which becomes even more important in the artificial pancreas context (where faster onset, shorter duration insulin is one crucial ingredient, combined with more accurate continuous glucose monitoring, and stable glucagon formulations).

Well, we already have Wal-Mart R and N, which I tend to classify as "generic" (even though everyone knows they are made by Novo Nordisk).

The patents are running out, or have run out, on Lantus and Humalog but it is not obvious that generic forms will come out soon from Mylan etc. because they have a huge learning curve to adopt to the insulin market. I would like to see Novo Nordisk do the "Generic" versions of Lantus and Humalog because I actually see them understanding the difficulties and market.

I personally would like to see the insurance companies abandon the "formulary" brands in favor of generics. A better term for formulary would be, "back-room deal between insurance company and drug maker". It hides all the true pricing information from the individuals using the medicine and puts the individuals at the whim of the latest back-room deals to choose what they get. I hate it.

All this stuff about generic and biosimilars and the cost of insulin is just complicated. A "generic" typically occurs when a synthetic molecule used in a patented drugs loses patent protection and other companies can apply to produce the drug with the same active ingredient. This is what happened to metformin which can be purchased for $4/month now in generic form. But insulin can't have generic, it is a biologic so it will have a biosimilar. Humalog lost patent protection in 2013 and Lantus will lose patent protect next year but I don't expect there to be a wave of biosimilar insulin products. I expect there to be maneuvers to continue protection and raise barriers to generics and biosimilar. And actually biosimilar drugs for patent protected drugs can already apply to the US market.

These biosimilar biologics are in fact different that synthetic molecules. The courts have found that you cannot patent naturally occurring molecules and that definition has overshadowed biologics, drugs produced from natural sources and in particular using rDNA technologies. There was a good discussion of generics back in february. Biocon has a valuable portfolio of biosimilar insulins including biosimilar forms of Lantus, Novolog and Humalog. And they have obtained significant investment and partnership with other companies. But in the end, the business interests will win. If they are able to enter the US market it will be only after major investment and only if they can make major money off the move, all of which points to expensive products.

I've come to believe that we have little hope of getting inexpensive effective insulin when we let profit making companies control the market. Greed will assure that competition stays weak and prices stay high.

Thanks Terrie, these links rovide very good info!!

Super reply, Niccolo, thanks!

Very good reply, Brian. Thanks for that!

I once heard the argument that generic insulin would not be a good idea, and that it is because of this that the companies that make insulin won't hand out their production and processing plans. While I'm not sure that the pharmaceutical companies will continue with this, I do agree with the fact that generic insulin might cause more problems than it solves.

I can tell you that there's a big difference between some generic pills and their brand-name companions. Even take metformin--I knew the difference between the brands whenever my pharmacy switched me. It didn't affect my BG control (which was pretty bad on met, anyway), but it did affect my GI tract, and I had different and/or worse side effects with different brands. The worst part was that I was often switched every two months, depending on what my pharmacy had available when I renewed my prescription.

Let's take another example. I have a friend who's a severe asthmatic. She told me that the different generic brands for the same medication in an inhaler acted differently with her--possibly based on the particle size of the spray in the different company's inhalers, possibly because of the additives or even a difference in potency. She now refuses to get all but one of the generic brands.

I know other people who share the same sentiment regarding other pills. If you think about the difference between store-brand and name-brand acetaminophen, ibuprofen, even Robitussin--sometimes they're the same, sometimes they're not. That's the potential problem with generic insulin.

Though the manufacturing process is closely monitored, it appears that the generic brands don't have the same motivation in ensuring that all of their products are exactly as good as the original. The name-brands really, really want you to use their drug because they make a huge profit off of it, but the generic brands are producing the same drug for cheaper, and they weren't the ones who put in the original research, either. They therefore have less invested in a "perfect" product. And while the FDA has standards for drugs and drug processing, I'm pretty sure I've heard that the name-brand drug company's processing standards are often higher than the national requirement.

Think about the difference between Novolog and Humalog. They're the "same" drug--insulin--but many people react differently to them. And yes, they're different, but like Brian said, the biologic generics won't be generics, they'll be biosimilars. Therefore, the difference between different generic forms of insulin might be the difference between Novolog and Humalog--or it could be more, or less. It's impossible to tell. And if there are multiple generic forms of insulin available on the market at the same time, you might get a different generic every month, which means an adjustment period every month to what is essentially a new brand of insulin.

I'm not saying that generic insulin is a bad idea, I just think that with something that's already so chancy, it may be difficult to get generics to all be the same with respect to quality, potency, and all the other things we take for granted to be stable in a vial of insulin.

Thanks , guitarnut, I am learning about "biosimilars".